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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34281
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2017
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k160229. (b)(4). The 1x echo-hd-22-ebus-o-c was returned to cook (b)(4) for evaluation. Upon evaluation of the returned device the following was noted: the device was returned in a plastic bag. There was no syringe returned. There was no stylet returned. There was no needle exposure. The needle advances and retracts without issue. The needle adjuster functions as intended. There is no functional damage noted. It was noted that the incorrect scope was used with the device. There was no brass insert protrusion on the needle adjuster and no cracking to the sheath adjuster noted. The customer complaint is confirmed based on customer testimony. A possible root cause to this occurrence may have been that the physician did not tightened the locking screw correctly a review of manufacturing records did not reveal any discrepancies that would have resulted in this occurrence. The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use". From the information provided there are no adverse effects to the patient caused by this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
During two passes while performing an ebus, the needle was locked the needle in place after being set up, it was double checked that it was firmly lock; the needle was fired, only to discover that the needle locking mechanism somehow loosened and the needle throw went farther than intended. User comment: "i always lock the needle in tightly and double check and never have had this happen before. ".
 
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Brand NameECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer Contact
michael galvin
o halloran road
national technology park
limerick 
061334440
MDR Report Key6861473
MDR Text Key87239014
Report Number3001845648-2017-00394
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34281
Device Catalogue NumberECHO-HD-22-EBUS-O-C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/12/2017
Event Location Hospital
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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